Thalidomide for the Treatment of Malnutrition Inflammation Syndrome in Peritoneal Dialysis Patients

NCT00390247 | Withdrawn Phase 4

• 1 other identifier: CRE-2006.291
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis In peritoneal dialysis (PD) patients, malnutrition, inflammation and atherosclerotic cardiovascular disease commonly coexist. The triad has been coined the "MIA syndrome". Proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-alpha), plays a central role in the pathogenesis of the MIA syndrome. Thalidomide selectively inhibits the production of TNF-alpha and represents a valuable anti-cytokine therapy. Specific Aim To study the effect of thalidomide in attenuating or reversing malnutrition and systemic inflammation in PD patients. Research Plan Design: Double-blinded randomised prospective placebo control trial. Setting: Renal unit of a university teaching hospital. Subjects: Sixty prevalent PD patients with evidence of malnutrition. Interventions: Patients will be randomised to receive either oral thalidomide 100 mg nocte or placebo. Main outcome measures: Patients will be followed for 1 year. Nutritional parameters including serum albumin, subjective global assessment, malnutrition-inflammation score, normalised protein nitrogen appearance, fat-free edema-free body mass and anthropometry measurements will be monitored. Systemic inflammatory markers such as serum C-reactive protein and IL-6 will be assayed. Hospitalisation, cardiovascular events, and overall patient survival will also be compared during study period. Expected Outcome Nutritional parameters and markers of systemic inflammation are expected to improve with thalidomide therapy. The magnitude of improvement in nutrition, as well as patient morbidity, will be compared with placebo. In Hong Kong, 80% of end-stage renal failure patients are treated with PD. Malnutrition, cardiovascular disease and systemic inflammatory response are all common in our clinical practice. They are major causes of patient morbidity and mortality. As a readily available anti-cytokine therapy, thalidomide may represent a valuable treatment of the MIA syndrome. The proposed study will provide important insight on the clinical benefit of thalidomide treatment in malnourished PD patients, which accounts for about one-third of our dialysis population.

Conditions

Peritoneal Dialysis; Malnutrition

Outcome Measures

Primary Outcomes (1)

• Nutritional status

  12 months

Secondary Outcomes (3)

• Change in arterial pulse wave velocity

  12 months

• Total number of days of hospital admission during study period

  12 months

• Composite cardiovascular end point

  12 months

Interventions

thalidomide DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. clinically stable adult patients (18 to 80 years old) on PD; and
• B. evidence of malnutrition:
• overall subjective global assessment score \< 5; or
• malnutrition inflammation score \> 9; or
• serum albumin \< 35 g/L C. written patient informed consent

You may not qualify if:

• Patients who are planned to have elective living donor transplant within 6 months Patients who are planned to transfer to other renal center within 6 months High likelihood of early withdrawal from the study (e.g. myocardial infarction, severe or unstable coronary disease, stroke, severe liver disease within 3 months) Active infection or systemic inflammatory disease. Current malignant disease Pregnancy or breast-feeding Women of childbearing potential with unreliable birth control methods Known hypersensitivity to thalidomide

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Renal Unit, Department of Medicine & Therapeutics, Prince of Wales Hospital

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Malnutrition

Interventions

Thalidomide

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Cheuk-Chun Szeto, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2006
• First Posted: October 19, 2006
• Study Start: January 1, 2007
• Study Completion: December 1, 2008
• Last Updated: February 9, 2016

Record last verified: 2007-04

Locations

HK (1)